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NCT03404115 · ClinicalTrials.gov registry record · Phase 2
A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
A Phase 2 study, sponsored by Aldeyra Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT03404115: Completed Phase 2 study, sponsored by Aldeyra Therapeutics.
NCT03404115 is a Phase 2 study that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03404115, a Phase 2 study, has completed, sponsored by Aldeyra Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study Summary
A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease
Primary Outcome
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort \& 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
Interventions
- DRUG Vehicle Ophthalmic Solution
- DRUG Reproxalap Ophthalmic Solution (0.25%)
- DRUG Reproxalap Ophthalmic Solution (0.1%)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2018-01-02 |
| Est. Completion | 2018-07-11 |
| Phase | Phase 2 |
What the finished NCT03404115 record still lists
NCT03404115 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 3 interventions - of which Vehicle Ophthalmic Solution is the first listed.
NCT03404115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03404115 about?
NCT03404115 is a clinical study titled "A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease". A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease
What is the current status of trial NCT03404115?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2018-01-02. Estimated completion is 2018-07-11.
What interventions are being tested in trial NCT03404115?
The interventions under investigation include: Vehicle Ophthalmic Solution (DRUG), Reproxalap Ophthalmic Solution (0.25%) (DRUG), Reproxalap Ophthalmic Solution (0.1%) (DRUG).
Who is sponsoring clinical trial NCT03404115?
This trial is sponsored by Aldeyra Therapeutics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03404115's enrollment target sits among peer trials
300 167th of 2000 higher than 1,813 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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